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May 2011

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Subject:
From:
Paul Zhao <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 30 Apr 2011 21:12:02 +0800
Content-Type:
text/plain
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Dear Chris,

You are right, USP/EP/JP methods are harmonzied sterility and MLT method for
2010 CP, and in China. I think USP/EP/JP is ok in China. BMS had facility in
Shanghai, you could just call them or email to them by your company internat
system. I think it would be more easy to gain the answer you are looking
for.

Best Regards,
Paul

2011/4/28 Knutsen, Chris <[log in to unmask]>

> I have been reviewing the Chinese Pharmacopeia method for sterility and
> microbial limits.  There are very significant differences from the USP/EP/JP
> harmonized sterility testing methods.  Is there anyone on this list who has
> experience with releasing products in China?  Will the harmonized sterility
> and MLT methods be accepted?
>
> Thank you for your input
>
>
>
> Chris Knutsen, Ph.D.
> Associate Director, Microbiology
> ABD
> Bristol-Myers Squibb Company
> 1 Squibb Drive
> New Brunswick, NJ 08902
> Tel : +1-732-227-5375
> Fax: +1-732-227-3071
> e-mail: [log in to unmask]<mailto:[log in to unmask]>
> 7asdf
>
>
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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

MicroBioLogics, Inc. - http://www.microbiologics.com

Millipore - http://www.millipore.com

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Veltek Associates, Inc - http://www.sterile.com

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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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